Drug Substance Process Operations Specialist required to provide operational support for manufacturing operations of the Late Stage and Launch Pipeline products at the new state of the art single use biotechnology facility in Co. Meath.
, Initially an 11 month contract.
Role: Reporting to the Process Operations Lead the Operations Specialist will support end-to end production operations for both Fed Batch and Continuous Manufacturing This role will involve supporting manufacturing operations on a Shift Rotation basis.
24/7 shift cycle.
Primary activities/responsibilities: Lead/Guide team members within the Production Operations team Coach and develop colleagues within the Production team Support team on shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure effective issue resolution Lead, facilitate and participate in cross-functional teams to collaborate effectively to cover compliance topics.
Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.
Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.
Lead complex process investigations on the production floor in support of deviation resolution.
Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external group.
Conduct all work activities with a strict adherence to the safety and compliance culture on site Participate in safety, process and environmental investigations.
Review alert and action limits as needed and implement corrective action as appropriate Write, review, and/or approve manufacturing documentation (SOPs, Manufacturing Records & Logbooks) Ensure the effective use of material, equipment and personnel in producing quality products.
Requirements: Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
4 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).
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Competent in analyzing complex situations and show practical problem-solving capabilities.
Ability to work independently and within a cross-functional team.
Understanding of multi column chromatography concepts Familiarity with contamination control and batch release requirements Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits Problem, Deviation, and Change Management experience Commissioning and Qualification experience Understanding of Upstream and Downstream Unit Operations for mAb manufacturing Familiarity with Emerson DeltaV, SIPAT, and the use of Automation in a manufacturing Process.
Skills: Drug Substance Process Operations Specialist Biotechnology, Process Engineering